A prosthetic system
By designing preset channels and occluders with specific angles in minimally invasive surgery, the surgical risk caused by control wire protrusion was resolved, enabling reliable adjustment and safe separation of the prosthesis and reducing surgical risks.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-09-08
- Publication Date
- 2026-03-31
AI Technical Summary
In minimally invasive surgery, the protrusions of the control wire can easily detach from the connecting shaft in the opposite direction to the preset direction, causing blockage with other components of the delivery device, prostheses, or certain organs in the human body, increasing the surgical risk.
A prosthesis system was designed, including a delivery device and a prosthesis. By coupling between the connecting shaft and the base, and utilizing the angle setting of the first preset channel and the sealing function of the sealing component, the control wire clamp is constrained within the channel to prevent it from slipping out, thereby achieving reliable control and separation of the prosthesis.
In minimally invasive surgery, the prosthesis is safely and reliably adjusted using control wires, reducing surgical risks and ensuring the safety and reliability of the prosthesis system.
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Figure CN115501001B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a prosthesis system. Background Technology
[0002] Minimally invasive surgery was developed to reduce harm to patients during surgical procedures. Minimally invasive surgery refers to a type of surgery that uses modern medical instruments, such as delivery devices, to transport a prosthesis to the target location through the body's natural cavities, and then manipulates the prosthesis using the delivery device to achieve the surgical objective.
[0003] Currently, there are various methods for manipulating prostheses through delivery devices in minimally invasive surgery. One method involves controlling the state of the prosthesis using a control wire that is connected to the prosthesis within the delivery device. Chinese patent document CN114302698A discloses a specific implementation method for controlling the state of the prosthesis using a control wire within a delivery device.
[0004] In Chinese patent document CN114302698A, one end of the control wire has a protrusion, and the other end of the control wire passes through a connecting shaft in a preset direction and extends to the prosthesis after being movably connected to it. At the same time, the protrusion is restricted from passing through the connecting shaft in the preset direction by the cooperation between the connecting shaft and the central rod of the conveying device, thereby facilitating the operator to operate the control wire at the proximal end of the conveying device to control the state of the prosthesis.
[0005] However, when performing surgery in this manner, the protruding end of the control wire is prone to slipping out of the connecting shaft in the opposite direction to the preset direction. This can cause the protruding end of the control wire to easily get stuck with other components of the delivery device, the prosthesis, or certain organs in the human body, resulting in a higher surgical risk. Summary of the Invention
[0006] The purpose of this application is to provide a prosthesis system that can safely and reliably adjust the state of the prosthesis while preventing the control wire from getting stuck with other components of the delivery device, the prosthesis, or certain organs in the human body, thereby reducing surgical risks.
[0007] To address the aforementioned problems, this application provides a prosthesis system, comprising: a delivery device and a prosthesis; the delivery device includes a connecting shaft and a first control wire; the prosthesis includes a base and a first movable member, wherein the base is detachably coupled to the connecting shaft; a first preset channel is disposed at an angle to the axis of the connecting shaft on the connecting shaft or the base, the first preset channel including a first port and a second port disposed opposite to each other; the first control wire includes a connected first body and a first locking body, the size of the first body at least at the point connected to the first locking body is smaller than the size of the first locking body, the first locking body is located within the first preset channel, and the first body extends from the first port out of the first preset channel for independently driving the movement of the first movable member; a sealing member is used to seal the second port to prevent the first locking body from exiting from the second port; wherein the first preset channel has a first state and a second state, when the first preset channel is in the first state, the first locking body is constrained within the first preset channel; when the first preset channel is in the second state, the first locking body is allowed to separate from the first preset channel from the first port.
[0008] The prosthesis system provided in this application embodiment, during minimally invasive surgery, allows the delivery device to connect to the prosthesis via coupling between the connecting shaft and the base, and enables the first preset channel to be in a first state, constraining the first locking body within the first preset channel. The prosthesis can then be delivered to the target position within the body via the delivery device through surgical pathways such as natural body cavities. When the prosthesis needs to be manipulated, the first preset channel remains in the first state, constraining the first locking body within it. The movement of the first movable component of the prosthesis can be adjusted using the first body extending from the first port through the first preset channel, thereby changing the state of the prosthesis to achieve implantation and thus achieve therapeutic or diagnostic purposes. After implantation, if the delivery device needs to be separated from the prosthesis, the first preset channel can be in a second state, allowing the first locking body to separate from the first port through the first preset channel. The first locking body can then be separated from the first preset channel by pulling the first body, and subsequently, the first control wire can be separated from the prosthesis by pulling the first body. At this point, the base of the prosthesis can be disassembled from the connecting shaft of the delivery device to separate the delivery device and the prosthesis, thereby facilitating the removal of the delivery device from the body to complete the implantation surgery. Thus, during minimally invasive surgery, when it is necessary to manipulate the prosthesis, the moving parts within the prosthesis can be safely and reliably adjusted via the first control wire of the delivery device to change the prosthesis's state.
[0009] When it is necessary to constrain the first card body within the first preset channel, the second port is sealed by a sealing member, thereby preventing the first card body from popping out of the second port. This avoids the first card body from popping out of the first preset channel in the opposite direction to the first body extending out of the first preset channel, as in prior art. Consequently, it prevents the part of the first control wire with the first card body from easily getting stuck with other components of the delivery device, the prosthesis, or certain organs in the human body, as in prior art. This reduces the surgical risk and allows the prosthesis system to complete the surgery safely and reliably. Attached Figure Description
[0010] Figure 1 A schematic diagram showing the coupling of the distal end of the delivery device with the mitral valve clamp for some embodiments of this application;
[0011] Figure 2 A schematic diagram of the clamping arm of the mitral valve clamp coupled to the delivery device, provided for some embodiments of this application, during its movement.
[0012] Figure 3 Schematic diagrams of the structure of the first and second control wires provided for some embodiments of this application;
[0013] Figure 4 for Figure 3 Enlarged view of part A in the middle;
[0014] Figure 5 A schematic cross-sectional view of a prosthesis system provided in some embodiments of this application located at a first preset channel;
[0015] Figure 6 A schematic diagram of the structure in which the connecting shaft and the central rod are located at the first preset channel, according to some embodiments of this application;
[0016] Figure 7 A schematic diagram of another structure provided for some embodiments of this application, in which the connecting shaft and the central rod are located at the first preset channel;
[0017] Figure 8 Exploded views of the connecting shaft and base provided for some embodiments of this application;
[0018] Figure 9 An exploded view of the structure of another connecting shaft and base provided for some embodiments of this application;
[0019] Figure 10 A schematic diagram of the structure of the prosthesis system located at the sealing element according to some embodiments of this application;
[0020] Figure 11 A cross-sectional view of the prosthesis system provided in some embodiments of this application, taken along the axis of the connecting shaft at the location of the occluder;
[0021] Figure 12 Schematic diagram of the structure of the sealing element provided in some embodiments of this application;
[0022] Figure 13 A three-dimensional structural schematic diagram of the sealing member provided for some embodiments of this application;
[0023] Figure 14 A schematic cross-sectional view of the prosthesis system provided in some embodiments of this application located at the second preset channel;
[0024] Figure 15 Schematic diagram of the structure of the mitral valve clip provided for some embodiments of this application;
[0025] Figure 16 A schematic diagram of the structure when the clamping arm and the control wire are engaged, provided for some embodiments of this application;
[0026] Figure 17 A schematic diagram of another structure provided for some embodiments of this application when the clamping arm is engaged with the control wire;
[0027] Figure 18 This application provides a schematic diagram of another configuration of the clamping arm and control wire in operation, illustrating some embodiments of the present application. 。
[0028] In the attached figures, the reference numerals are as follows:
[0029] Conveying device 100, connecting shaft 110, first receiving section 111, first contact surface 112, first distal blocking surface 113, first proximal blocking surface 114, first inclined surface 115, protrusion 116, third distal blocking surface 117, first connecting surface 118, third proximal blocking surface 119, first control wire 120, first body 121, first clamping body 122, center rod 130, second control wire 140, second body 141, second clamping body 142, guide tube 150;
[0030] Mitral valve clip 200, base 210, second receiving section 211, second contact surface 212, second distal blocking surface 213, second proximal blocking surface 214, second inclined surface 215, groove 216, fourth distal blocking surface 217, second connecting surface 218, fourth proximal blocking surface 219, first clamping arm 220, transition section 221, fixing wire 222, fixing wire body 223, fixing knot 224, second through hole 225, third through hole 226, protrusion 227, fourth through hole 228, second clamping arm 230, first clamping seat 240, second clamping seat 250, first connecting rod 261, second connecting rod 262, slider 263;
[0031] First preset channel 300, straight groove 301, first wall hole 302, second wall hole 303, first hole wall portion 304, second hole wall portion 305, first port 310, second port 320, limited space 330, limiting segment 340;
[0032] The sealing component is 400, the first opening is 410, the second engaging part is 420, and the second opening is 430;
[0033] Preset segment 500, first locking part 510;
[0034] The second preset channel is 600, the third port is 610, and the fourth port is 620;
[0035] Mitral valve 700, first leaflet margin 710, second leaflet margin 720. Detailed Implementation
[0036] Those skilled in the art will understand that many technical details have been presented in the various embodiments of this application to facilitate a better understanding of the application. However, the technical solutions claimed in this application can also be achieved based on various variations and modifications of the following embodiments.
[0037] In the various embodiments of this application, "proximal end" and "proximal side" refer to the end that is closer to the operator and further away from the patient; correspondingly, "distal end" and "distal side" refer to the end that is closer to the patient and further away from the operator. In the various embodiments of this application, "parallel" and "perpendicular" should not be narrowly interpreted as 0° or 90°, but should be understood as a reasonable angle range that includes 0° or 90° and has a certain degree of fluctuation, provided that the technical effect is achieved.
[0038] This application provides a prosthesis system in some embodiments, including: a delivery device and a prosthesis; the delivery device includes a connecting shaft and a first control wire; the prosthesis includes a base and a first movable member, wherein the base is detachably coupled to the connecting shaft; a first preset channel is disposed at an angle to the axis of the connecting shaft on the connecting shaft or the base, the first preset channel includes a first port and a second port disposed opposite to each other; the first control wire includes a first body and a first locking body connected together, the size of the first body at least at the point connected to the first locking body is smaller than the size of the first locking body, the first locking body is located in the first preset channel, the first body extends from the first port out of the first preset channel for independently driving the movement of the first movable member; a sealing member is used to seal the second port to prevent the first locking body from popping out from the second port; wherein the first preset channel has a first state and a second state, when the first preset channel is in the first state, the first locking body is constrained in the first preset channel; when the first preset channel is in the second state, the first locking body is allowed to separate from the first preset channel from the first port.
[0039] The prosthesis system provided in some embodiments of this application allows for the connection of a delivery device to the prosthesis during minimally invasive surgery via coupling between the connecting shaft and the base. This enables the first preset channel to be in a first state, constraining the first locking body within the first preset channel. Subsequently, the prosthesis can be delivered to the target position within the human body via the delivery device through surgical pathways such as natural body cavities. When the prosthesis needs to be manipulated, the first preset channel remains in the first state, constraining the first locking body within the first preset channel. The movement of the first movable component of the prosthesis can be adjusted using the first body extending from the first port of the first preset channel, thereby changing the state of the prosthesis to achieve implantation and thus achieve the purpose of treatment and diagnosis. After implantation, if the delivery device needs to be separated from the prosthesis, the first preset channel can be in a second state, allowing the first locking body to be separated from the first preset channel from the first port. The first locking body can then be separated from the first preset channel by pulling the first body, and subsequently, the first control wire can be separated from the prosthesis by pulling the first body. At this point, the base of the prosthesis can be disassembled from the connecting shaft of the delivery device to separate the delivery device and the prosthesis, thereby facilitating the removal of the delivery device from the body to complete the implantation surgery. Thus, during minimally invasive surgery, when it is necessary to manipulate the prosthesis, the moving parts within the prosthesis can be safely and reliably adjusted via the first control wire of the delivery device to change the prosthesis's state.
[0040] When it is necessary to constrain the first card body within the first preset channel, the second port is sealed by a sealing member, thereby preventing the first card body from popping out of the second port. This avoids the first card body from popping out of the first preset channel in the opposite direction to the first body extending out of the first preset channel, as in prior art. Consequently, it prevents the part of the first control wire with the first card body from easily getting stuck with other components of the delivery device, the prosthesis, or certain organs in the human body, as in prior art. This reduces the surgical risk and allows the prosthesis system to complete the surgery safely and reliably.
[0041] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the various embodiments of this application will be described in detail below with reference to the accompanying drawings.
[0042] See Figures 1 to 18The prosthetic system provided in some embodiments of this application includes: a delivery device 100 and a prosthesis; the delivery device 100 includes a connecting shaft 110 and a first control wire 120; the prosthesis includes a base 210 and a first movable member, wherein the base 210 is detachably coupled to the connecting shaft 110; a first preset channel 300 is provided at an angle to the axis of the connecting shaft 110 on the connecting shaft 110 or the base 210, the first preset channel 300 includes a first port 310 and a second port 320 disposed opposite to each other; the first control wire 120 includes a connected first body 121 and a first locking body 122, wherein the size of the first body 121 at least at the connection with the first locking body 122 is smaller. Regarding the size of the first card body 122, the first card body 122 is located within the first preset channel 300. The first body 121 extends from the first port 310 into the first preset channel 300 to independently drive the movement of the first movable member. The sealing member 400 is used to seal the second port 320 to prevent the first card body 122 from popping out from the second port 320. The first preset channel 300 has a first state and a second state. When the first preset channel 300 is in the first state, the first card body 122 is constrained in the first preset channel 300. When the first preset channel 300 is in the second state, the first card body 122 is allowed to separate from the first preset channel 300 from the first port 310.
[0043] Here, the first preset channel 300 being angled to the axis of the connecting shaft 110 or the base 210 means that the extension direction of the first preset channel 300 has an angle greater than 0° and less than 180° with the axis of the connecting shaft 110, and the first preset channel 300 is disposed on the connecting shaft 110 or the base 210. Preferably, the extension direction of the first preset channel 300 is perpendicular to the axis of the connecting shaft 110.
[0044] Here, "size" refers to the dimension of a cross-section perpendicular to the extension direction. For example, the size of the first port 310 is the cross-sectional dimension of the first port 310 perpendicular to the extension direction of the first preset channel 300. When the cross-section of the first port 310 is a circular hole, the size of the first port 310 is the diameter of the cross-section of the first port 310. When the first port 310 is a non-circular hole, the size of the first port 310 is the size obtained according to a specific rule, such as twice the distance from the geometric center of its cross-section to a point on the cross-section. In one embodiment, the size of the first port 310 is the diameter of the circumcircle of the first port 310. The same applies to the size of the second port 320 and even the sizes of various locations on the first control wire 120, which will not be described further here.
[0045] Preferably, the dimensions of the first port 310 and the second port 320 are comparable; that is, the first port 310 and the second port 320 are designed with the same dimensions and manufactured to the same dimensions. However, due to factors such as manufacturing precision and errors, there may be slight deviations between the dimensions of the first port 310 and the second port 320. This facilitates the processing of the first port 310 and the second port 320 to form the first preset channel 300.
[0046] like Figure 3 and Figure 4 To facilitate the manufacture of the first control wire 120, the dimensions of the first body 121 are identical at all points. That is, the dimensions of the first body 121 where it connects to the first card body 122 are the same as the dimensions of the other parts of the first body 121. In this case, the dimensions of any part of the first body 121 are smaller than the dimensions of the first card body 122.
[0047] Alternatively, the dimension of the part of the first body 121 that is connected to the first card body 122 is smaller than the dimension of other parts of the first body 121.
[0048] Furthermore, this embodiment does not impose any particular restrictions on the shape of the first body 121. For example, the first body 121 can be spherical, hemispherical, spherical crown-shaped, spherical notch-shaped, or ellipsoidal.
[0049] In some embodiments, the first movable member is configured to move relative to the base 210. Further, the first movable member may be directly and movably connected to the base 210, or it may be movably connected to the base 210 via other components; this application does not limit the specific embodiment. For example, the first movable member may be wrapped around the surface of the base 210 or the prosthesis and moved away from the base 210 or the prosthesis under the drive of the first control wire 120. As another example, the first movable member may be rotatable relative to the base 210 and rotate towards or away from the base 210 under the drive of the first control wire 120.
[0050] In some embodiments, since the first body 121 needs to control the movement of the first moving part, the first control wire 120 is made of a rigid material with a large elastic modulus, such as medical stainless steel or titanium alloy.
[0051] In some embodiments, the first preset channel 300 and the first control wire 120 are configured in terms of their respective dimensions so that when the first preset channel 300 is in a first state, the first card body 122 is constrained within the first preset channel 300; and when the first preset channel 300 is in a second state, the first card body 122 is allowed to separate from the first preset channel 300 at the first port 310.
[0052] The size of the first preset channel 300 in the first state is different from the size of the first preset channel 300 in the second state. Specifically, when the first preset channel 300 is in the first state, the minimum size of the first preset channel 300 is the first size, which is at least larger than the size at the connection between the first body 121 and the first card body 122 and smaller than the size of the first card body 122; when the first preset channel 300 is in the second state, the minimum size of the first preset channel 300 is the second size, which is larger than the size of the first card body 122.
[0053] Wherein, "when the first preset channel 300 is in the first state, the minimum size of the first preset channel 300 is the first size" means that when the first preset channel 300 is in the first state, the minimum cross-sectional size of the first preset channel 300 in each cross-section perpendicular to the extension direction of the first preset channel 300. Correspondingly, "when the first preset channel 300 is in the second state, the minimum size of the first preset channel 300 is the second size" means that when the first preset channel 300 is in the second state, the minimum cross-sectional size of the first preset channel 300 in each cross-section perpendicular to the extension direction of the first preset channel 300.
[0054] By setting the first size to be at least larger than the size of the connection between the first body 121 and the first card body 122 but smaller than the size of the first card body 122, it is advantageous that at least the portion of the first body 121 connected to the first card body 122 can be accommodated within the first preset channel 300 in the first state, and that the first card body 122 is constrained within the first preset channel 300 in the first state. By setting the second size to be larger than the size of the first card body 122, it is ensured that the first card body 122 can pass through the first preset channel 300 in the second state, so that the first control wire 120 can be separated from the first preset channel 300 in the second state.
[0055] In some embodiments, the conveying device 100 further includes a central rod 130, and the size of the first preset channel 300 is adjusted by controlling whether the central rod 130 overlaps with the first preset channel 300. Specifically, the connecting shaft 110 is provided with a receiving channel arranged along the axial direction of the connecting shaft 110, or the connecting shaft 110 and the base 210 are provided with a receiving channel arranged along the axial direction of the connecting shaft 110; the central rod 130 is movably received in the receiving channel; wherein, the receiving channel intersects with the first preset channel 300, and the area where the receiving channel intersects and overlaps with the first preset channel 300 is an overlapping area; when the central rod 130 occupies at least part of the overlapping area, the first preset channel 300 is in a first state; when the central rod 130 is outside the overlapping area, the first preset channel 300 is in a second state.
[0056] In this way, the second size can be larger than the first size, thereby facilitating the requirement that the first size is larger than the size at the connection point between the first body 121 and the first card body 122, and smaller than the size of the first card body 122, and that the second size is larger than the size of the first card body 122.
[0057] Furthermore, the first preset channel 300 can be switched from a first state to a second state. For example, when it is necessary to switch the first preset channel 300 from the first state to the second state, it is only necessary to position the center rod 130 outside the overlapping area.
[0058] See Figure 5 and simultaneously combined Figure 6 and Figure 7 The first preset channel 300 is disposed on the connecting shaft 110; the receiving channel includes a first receiving section 111 disposed on the connecting shaft 110, the first receiving section 111 and the first preset channel 300 are configured to at least partially overlap, and the overlapping area is an overlapping area. When the center rod 130 occupies at least partially overlapping area, the first preset channel 300 is in a first state; and when the center rod 130 is located outside the overlapping area, the first preset channel 300 is in a second state.
[0059] Combination Figure 8 and Figure 9 Alternatively, the receiving channel includes a first receiving section 111 disposed on the connecting shaft 110 and a second receiving section 211 disposed on the base 210, wherein the first receiving section 111 and the second receiving section 211 are interconnected when the base 210 is coupled to the connecting shaft 110. In this case, the first preset channel 300 may be disposed on the base 210; the second receiving section 211 and the first preset channel 300 are configured to at least partially overlap, and the overlapping area is an overlapping area. When the center rod 130 moves from the first receiving section 111 to the second receiving section 211 and enters the second receiving section 211 through the connection between the first receiving section 111 and the second receiving section 211, and occupies at least part of the overlapping area, the first preset channel 300 is in a first state; while when the center rod 130 is located outside the overlapping area, the first preset channel 300 is in a second state.
[0060] Furthermore, the size of the overlapping region is smaller than the second dimension. For example... Figure 6Taking the first preset channel 300 disposed on the connecting shaft 110 as an example, the first preset channel 300 forms a through groove 301 on the inner wall of the connecting shaft 110, and also forms a first wall hole 302 on the connecting shaft 110 opposite to the through groove 301. The first receiving section 111 partially overlaps with the first preset channel 300, and the area corresponding to the first wall hole 302 is the overlapping area. When the center rod 130 occupies at least part of the overlapping area, the first preset channel 300 is in a first state, and the space of the first preset channel 300 is defined by the through groove 301 and the portion of the outer surface of the center rod 130 corresponding to the through groove 301. When the center rod 130 does not occupy the overlapping area, that is, when the center rod 130 is located outside the overlapping area, the first preset channel 300 is in a second state. At this time, both the through groove 301 and the first wall hole 302 are used to accommodate the first control wire 120, and the space of the first preset channel 300 includes the space defined by the through groove 301 and the first wall hole 302. Correspondingly, when the first preset channel 300 is set on the base 210, it may also have a straight through groove 301 and a first wall hole 302 with the same functions as described above, which will not be described in detail here. Figure 8 The first preset channel 300 shown is also arranged in the same way, the difference being that the first preset channel 300 is located on the base 210.
[0061] The size of the overlapping region can also be equal to the second size. For example... Figure 7 Taking the example of a first preset channel 300 being disposed on a connecting shaft 110, the first preset channel 300 forms a second wall hole 303 penetrating the connecting shaft 110. The first preset channel 300 completely overlaps with the first receiving section 111, and the area defined by the second wall hole 303 is the overlapping area. The size of the central rod 130 is smaller than the size of the first receiving section 111, so the central rod 130 can only occupy part of the overlapping area. Therefore, the second wall hole 303 is divided into a first hole wall portion 304 corresponding to the overlapping area that can be occupied by the central rod 130 and a second hole wall portion 305 corresponding to the overlapping area that cannot be occupied by the central rod 130. When the central rod 130 occupies part of the overlapping area, the first preset channel 300 is in a first state, and the space of the first preset channel 300 is defined by the second hole wall portion 305 and the corresponding portion of the outer surface of the central rod 130. When the center rod 130 does not occupy the overlapping area, the first preset channel 300 is in the second state. At this time, both the first hole wall portion 304 and the second hole wall portion 305 can be used to accommodate the first control wire 120. The space of the first preset channel 300 includes the space defined by the first hole wall portion 304 and the second hole wall portion 305, that is, the space defined by the second wall hole 303. Correspondingly, when the first preset channel 300 is set on the base 210, it can also have a second wall hole 303 with the same function as described above, which will not be described in detail here. Figure 9The first preset channel 300 shown is also arranged in the same way, the difference being that the first preset channel 300 is located on the base 210.
[0062] Accordingly, such as Figure 5 When the first preset channel 300 is in the first state, the first card body 122 is located in the limited space 330 defined by the sealing member 400, the central rod 130 and the first preset channel 300; a limiting section 340 is formed between the outer surface of the central rod 130 and the wall surface on the opposite side of the overlapping area in the first preset channel 300; the first body 121 extends from the limited space 330, and after passing through the limiting section 340, extends out of the first preset channel 300 from the first port 310.
[0063] The defined space 330, defined by the sealing member 400, the center rod 130 and the first preset channel 300, refers to the defined space 330 jointly defined by the part of the sealing member 400 used to block the second port 320, the part of the center rod 130 facing the second port 320, and the part of the wall of the first preset channel 300 located near the second port 320.
[0064] The limiting segment 340 is the portion of the first preset channel 300 located in the overlapping area that is not occupied by the center rod 130 after the center rod 130 occupies the overlapping area.
[0065] Furthermore, when the first preset channel 300 is in the first state, the size of the limiting segment 340 is the third size, which is larger than the size at the connection between the first body 121 and the first card body 122 but smaller than the size of the first card body 122. Thus, when the first preset channel 300 is in the first state, the limiting segment 340 can be used to constrain the first card body 122 to the side of the limiting segment 340 near the second port 320, that is, the limiting segment 340 can be used to constrain the first card body 122 within the defined space 330.
[0066] Furthermore, when the first preset channel 300 is in the first state, the size of the first preset channel 300 at the limiting segment 340 is the minimum size. Thus, when the first preset channel 300 is in the first state, the connection between the first body 121 and the first card body 122 can be easily housed in the limiting segment 340 or even in the portion of the first preset channel 300 located on the side of the limiting segment 340 near the first port 310.
[0067] In some embodiments, the blocking element 400 is configured to cover the second port 320 to block the port. In other embodiments, the blocking element 400 is configured to block the second port 320 to block the port.
[0068] In some embodiments, the portion of the connecting shaft 110 or base 210 with the first preset channel 300 is a preset segment 500; the sealing member 400 is a hollow structure, and the sealing member 400 is sleeved and fixed on the preset segment 500, with a portion of the inner wall surface of the sealing member 400 configured to cover the second port 320 to seal the port. By configuring a portion of the inner wall surface of the sealing member 400 sleeved on the preset segment 500 to cover the second port 320 to seal the port, the first card 122 located in the first preset channel 300 can be prevented from popping out of the second port 320.
[0069] Furthermore, the sealing member 400 is also provided with a first opening 410, which is positioned directly opposite the first port 310 to expose the port. The size of the first opening 410 is greater than or equal to the size of the first card body 122. By positioning the first opening 410 on the sealing member 400 directly opposite the first port 310 to expose the port, it is convenient for the first body 121 to extend out of the sealing member 400 through the first opening 410 after extending out of the first port 310 of the first preset channel 300. When the first preset channel 300 is in the second state, because the size of the first opening 410 is greater than or equal to the size of the first card body 122, the first card body 122 can be disengaged from the first port 310 and then disengaged from the sealing member 400 through the first opening 410.
[0070] Preferably, the shape of the first opening 410 matches the cross-sectional shape of the first port 310. Preferably, the size of the first opening 410 is greater than or equal to the size of the first port 310. In this way, after the first card body 122 is disengaged from the first preset channel 300 from the first port 310, it is easy for the first card body 122 to be disengaged from the sealing member 400 from the first opening 410.
[0071] Furthermore, the outer wall surface of the preset segment 500 has a first engaging portion 510, and the inner wall surface of the sealing member 400 has a second engaging portion 420. When the sealing member 400 is fitted onto the preset segment 500, the second engaging portion 420 engages with the first engaging portion 510. Thus, after the sealing member 400 is fitted onto the preset segment 500, the engagement between the first engaging portion 510 and the second engaging portion 420 prevents the sealing member 400 from moving relative to the preset segment 500. This ensures that after the sealing member 400 is fitted onto the preset segment 500, a portion of the inner wall surface of the sealing member 400 can always cover the second port 320, and the first opening 410 on the sealing member 400 can always face the first port 310.
[0072] In one specific embodiment, the first engaging portion 510 is a recessed portion formed by the inward indentation of the outer wall surface of the preset segment 500. In this case, the diameter of the outer wall surface of the recessed portion is smaller than the diameter of the outer wall surface of other parts of the preset segment 500. The second engaging portion 420 is a contracting portion formed by the inward contraction of the inner wall surface of the sealing member 400. In this case, the diameter of the inner wall surface of the contracting portion is smaller than the diameter of the inner wall surface of other parts of the sealing member 400. Thus, when the sealing member 400 is fitted onto the preset segment 500, the contracting portion can engage with the recessed portion to achieve mutual engagement between the first engaging portion 510 and the second engaging portion 420.
[0073] In the above embodiment, the number of recesses can be one, and the recesses are arc-shaped or annular, arranged circumferentially along the preset segment 500. In this way, when the first engaging portion 510 and the second engaging portion 420 engage, the fixation between the first engaging portion 510 and the second engaging portion 420 can be made more secure.
[0074] The number of the aforementioned recesses can also be multiple, with multiple recesses arranged circumferentially along the preset segment 500. The number of the aforementioned contraction portions is the same as the number of the aforementioned recesses, with each contraction portion corresponding to one recess. Thus, when each contraction portion is respectively engaged in a recess, that is, when the first engaging portion 510 and the second engaging portion 420 engage with each other, it can also prevent the sealing member 400 from rotating circumferentially relative to the preset segment 500, thereby further ensuring that part of the inner wall surface of the sealing member 400 can always cover the second port 320, and that the first opening 410 on the sealing member 400 can always face the first port 310.
[0075] Alternatively, the first engaging portion 510 is a protrusion formed by the outer wall of the preset segment 500 protruding outwards, and the second engaging portion 420 is an expansion portion formed by the inner wall of the sealing member 400 expanding outwards. In this way, when the sealing member 400 is fitted onto the preset segment 500, the protrusion can also engage with the expansion portion to achieve mutual engagement between the first engaging portion 510 and the second engaging portion 420.
[0076] See Figure 5 and combined Figures 10 to 13 In some specific embodiments, the cross-section of the sealing member 400 is O-shaped or O-like. Specifically, the cross-sectional shape of the sealing member 400 can be annular; the cross-sectional shape of the sealing member 400 can also be a closed shape such as an inner circle or an outer polygon, for example, an inner circle and an outer square. In this case, when the sealing member 400 is provided with a first opening 410, the first opening 410 can be formed by hole processing of the sealing member 400 after the sealing member 400 is formed. Of course, the first opening 410 can also be formed directly during the forming of the sealing member 400 without subsequent processing. This application does not limit the specific way in which the first opening 410 is formed on the sealing member 400 in this embodiment.
[0077] In some alternative embodiments, the cross-section of the sealing member 400 is not completely closed, such as C-shaped or U-shaped. Thus, the sealing member 400 forms a first opening extending axially along its axis. In this case, similar to the embodiments described above, the sealing member 400 can be fitted and fixed (e.g., by clipping, adhesive, etc.) onto the preset segment 500, and a portion of the inner wall surface of the sealing member 400 is configured to cover the second port 320, while the first opening is configured to face the first port 310 to expose that port. The size of the first opening is greater than or equal to the size of the first clip body 122.
[0078] In some alternative embodiments, the occluder 400 is a sheet-like structure. The occluder 400 is fixed (e.g., by adhesive) to the predetermined segment 500, and at least a portion of the inner wall surface of the occluder 400 is configured to cover the second port 320. For example, the occluder 400 is medical tape.
[0079] In some alternative embodiments, the plug 400 includes a covering portion and a blocking portion, the blocking portion being slightly larger than the second port 320, and the blocking portion is inserted into the second port 320 to block the second port 320; the covering portion is larger than the blocking portion so that the covering portion is positioned outside the second port 320 and does not enter the second port 320. For example, the plug 400 is a T-shaped silicone plug.
[0080] This embodiment does not impose any particular limitations on the material of the sealing member 400. Those skilled in the art can select appropriate materials depending on the different fixing methods of the sealing member 400 and the preset segment 500. For example, when the sealing member 400 is tightly bound to the preset segment 500, the sealing member 400 is made of an elastic polymer material, or the sealing member 400 is a heat-shrink tubing. In this way, when the sealing member 400 is tightly bound to the preset segment 500, it is easy for the inner wall surface of the sealing member 400 to fit tightly with the outer wall surface of the preset segment 500. Furthermore, when the preset segment 500 has the aforementioned recessed portion, the sealing member 400 can easily form the aforementioned contraction portion at the position corresponding to the recessed portion; and when the preset segment 500 has the aforementioned protrusion, the sealing member 400 can easily form the aforementioned expansion portion at the position corresponding to the protrusion.
[0081] Furthermore, when the sealing element 400 is made of an elastic polymer material, its inner diameter is smaller than the outer diameter of the corresponding part of the preset segment 500, so as to achieve a tight fit on the preset segment 500. When the sealing element 400 is a heat-shrinkable tubing, its inner diameter is larger than the outer diameter of the corresponding part of the preset segment 500. After being fitted onto the preset segment 500, the sealing element 400 is heated to reduce its inner diameter, so that it fits snugly against the outer surface of the preset segment 500. In this way, when the sealing element 400 is fitted onto the preset segment 500, it can be ensured that the inner wall surface of the sealing element 400 is tightly fitted against the outer wall surface of the preset segment 500.
[0082] In addition, the sealing element 400 can also be made of other materials, such as metal. In this case, the shape and size of the sealing element 400 match the shape and size of the preset segment 500, and the two are bonded together with adhesive when the sealing element 400 is fitted onto the preset segment 500. By using adhesive to bond and fix the sealing element 400 to the preset segment 500, movement and rotation of the sealing element 400 relative to the preset segment 500 can be prevented.
[0083] On the other hand, since the prosthesis needs to be delivered into the human body, the material used to prepare the occlusion component 400 must also be biocompatible. This ensures that the occlusion component 400 has good biocompatibility with the human body, thereby avoiding rejection reactions. Furthermore, if adhesive bonding is used, the adhesive should be a biocompatible adhesive, which also ensures good biocompatibility and avoids rejection reactions.
[0084] When the preset segment 500 is set on the base 210, the preset segment 500 is part of the prosthesis. The material used to prepare the occlusion element 400 is preferably biodegradable. Since the prosthesis needs to be implanted in the body long-term after surgery, the occlusion element 400 fixed to the preset segment 500 will remain in the body for an extended period. By using a biodegradable material to prepare the occlusion element 400, the occlusion element 400 left in the body can be degraded by the body, thus avoiding rejection symptoms such as thrombosis and inflammation caused by long-term retention.
[0085] See also Figure 1 and Figure 2 and combined Figure 14In some embodiments, the conveying device 100 further includes a second control wire 140; the prosthesis further includes a second movable member; a second preset channel 600, which is angled to the axis of the connecting shaft 110 and disposed on the connecting shaft 110 or the base 210, the second preset channel 600 including a third port 610 and a fourth port 620 disposed opposite to each other; the second control wire 140 includes a connected second body 141 and a second locking body 142, the size of the second body 141 at least at the part connected to the second locking body 142 is smaller than the size of the second locking body 142, the second locking body 142 is located within the second preset channel 600, and the second body 141 extends from... A second preset channel 600 extends from the third port 610 to independently drive the movement of the second movable member; the sealing member 400 is also used to seal the fourth port 620 to prevent the second locking body 142 from popping out from the fourth port 620; wherein, the second preset channel 600 has a first state and a second state. When the second preset channel 600 is in the first state, the second locking body 142 is constrained in the second preset channel 600 so that the connection between the second body 141 and the second locking body 142 is constrained; when the second preset channel 600 is in the second state, the second locking body 142 is allowed to separate from the second preset channel 600 from the third port 610.
[0086] When it is necessary to separate the delivery device 100 from the prosthesis, the first preset channel 300 can be in a second state, thereby allowing the first control wire 120 to disengage from the first preset channel 300, so as to facilitate the extraction of the first control wire 120 from the body and the separation of the first movable component of the prosthesis. Simultaneously, the second preset channel 600 can be in a second state, thereby allowing the second control wire 140 to disengage from the second preset channel 600, so as to facilitate the extraction of the second control wire 140 from the body and the separation of the second movable component of the prosthesis.
[0087] Preferably, the dimensions of the third port 610 and the fourth port 620 are comparable. It should be noted that the specific meaning of "the dimensions of the third port 610 and the fourth port 620 are comparable" is the same as the specific meaning of "the dimensions of the first port 310 and the second port 320 are comparable" as described above, and will not be repeated here. The dimensional fit between the second body 141 and the second card body 142 is the same as the dimensional fit between the first body 121 and the first card body 122 as described above, and will not be repeated here.
[0088] Furthermore, the dimensional fit between the second control wire 140 and the second preset channel 600 is the same as that between the first control wire 120 and the first preset channel 300, and will not be repeated here. Similarly, the structural relationship between the second control wire 140 and the second preset channel 600 is also the same as that between the first control wire 120 and the first preset channel 300, and will not be repeated here.
[0089] Alternatively, the second preset channel 600 can also be in the first and second states by using the central rod 130. The specific implementation method for using the central rod 130 to achieve the first and second states of the second preset channel 600 can be found in the detailed implementation method described above for using the central rod 130 to achieve the first and second states of the first preset channel 300, and will not be repeated here.
[0090] Furthermore, this embodiment does not impose any particular limitation on the number of sealing components 400. For example, when both the first preset channel 300 and the second preset channel 600 are disposed on the connecting shaft 110, or when both the first preset channel 300 and the second preset channel 600 are disposed on the base 210, one sealing component 400 can be used to seal both the second port 320 and the fourth port 620, or two sealing components 400 can be used to seal the second port 320 and the fourth port 620 respectively.
[0091] When the first preset channel 300 is disposed on the connecting shaft 110 and the second preset channel 600 is disposed on the base 210, the number of sealing members 400 can be two: one sealing member 400 disposed on the connecting shaft 110 to seal the second port 320, and the other sealing member 400 disposed on the base 210 to seal the fourth port 620. The sealing member 400 used to seal the fourth port 620 can also be made of the materials mentioned in the above embodiments.
[0092] It should be noted that the cooperation relationship between the sealing member 400 and the second preset channel 600 is the same as the cooperation relationship between the sealing member 400 and the first preset channel 300. For example, the fourth port 620 is sealed by covering or blocking; or, for example, the sealing member 400 is also provided with a second opening 430 that has the same function as the first opening 410, so as to expose the third port 610. Other details will not be elaborated here. It should also be noted that when there are two sealing members 400, the fixing relationship between the sealing member 400 used to seal the fourth port 620 and the base 210 (or connecting shaft 110) is the same as the fixing relationship between the sealing member 400 used to seal the second port 320 and the preset segment 500, and will not be elaborated here.
[0093] Furthermore, this embodiment does not impose any particular restrictions on the positions of the first preset channel 300 and the second preset channel 600. For example, both the first preset channel 300 and the second preset channel 600 may be disposed on the connecting shaft 110, or both may be disposed on the base 210, or the first preset channel 300 may be disposed on the connecting shaft 110 and the second preset channel 600 on the base 210. When both the first preset channel 300 and the second preset channel 600 are disposed on the connecting shaft 110 or the base 210, the axis of the first preset channel 300 and the axis of the second preset channel 600 are misaligned or parallel in the axial direction of the connecting shaft 110. In this way, the circumferential relative relationship between the first preset channel 300 and the second preset channel 600 can be freely adjusted, and the dimensions of both the first preset channel 300 and the second preset channel 600 can be made larger. Alternatively, the axis of the first preset channel 300 and the axis of the second preset channel 600 may intersect and be arranged at an angle. This allows the pre-defined segment 500 to have a smaller dimension in its extension direction.
[0094] This embodiment does not impose any particular limitation on the specific manner in which the connecting shaft 110 and the base 210 are detachably coupled. For example, see... Figure 8 The connecting shaft 110 has a first contact surface 112; the base 210 has a second contact surface 212 for contacting the first contact surface 112 when the connecting shaft 110 and the base 210 are coupled; the first contact surface 112 and the second contact surface 212 are configured such that the contact portion of the second contact surface 212 with the first contact surface 112 causes the connecting shaft 110 to be constrained to move radially relative to the base 210 when the connecting shaft 110 moves axially away from the base 210. Thus, constraining the connecting shaft 110 to move axially relative to the base 210 can be transformed into only constraining the connecting shaft 110 to move radially relative to the base 210, facilitating coupling between the connecting shaft 110 and the base 210.
[0095] Specifically, the first contact surface 112 includes a distal first distal blocking surface 113, a proximal first proximal blocking surface 114, and a first inclined surface 115 located between the first distal blocking surface 113 and the first proximal blocking surface 114; the second contact surface 212 includes a distal second distal blocking surface 213 for engaging with the first distal blocking surface 113, a proximal second proximal blocking surface 214 for engaging with the first proximal blocking surface 114, and a second inclined surface 215 located between the second distal blocking surface 213 and the second proximal blocking surface 214 for engaging with the first inclined surface 115; the maximum vertical distance from the first inclined surface 115 to the edge of the connecting shaft 110 (e.g., Figure 8 The value of H (in the middle) decreases as the distance to the far end of the base 210 increases.
[0096] By providing the first inclined surface 115, the contact portion between the second contact surface 212 and the first contact surface 112 can be such that when the connecting shaft 110 moves axially upward away from the base 210, the connecting shaft 110 simultaneously moves radially relative to the base 210. Furthermore, the first inclined surface 115 can be an inclined surface, a curved surface, or a wavy surface. Preferably, the first inclined surface 115 is an inclined surface or a curved surface. This facilitates the manufacturing of the first inclined surface 115.
[0097] Furthermore, the center rod 130 is configured such that when the center rod 130 is located at the coupling point between the connecting shaft 110 and the base 210, the connecting shaft 110 and the base 210 remain at least radially relative to each other, thereby achieving coupling between the connecting shaft 110 and the base 210. Thus, in conjunction with the aforementioned embodiment where "the contact portion between the second contact surface 212 and the first contact surface 112 such that when the connecting shaft 110 moves axially upwards away from the base 210, the connecting shaft 110 is constrained to move radially relative to the base 210," coupling between the connecting shaft 110 and the base 210 can be achieved by utilizing the center rod 130 to ensure that the connecting shaft 110 and the base 210 remain at least radially relative to each other.
[0098] Specifically, the connecting shaft 110 and the base 210 can be provided with a receiving channel arranged along the axial direction of the connecting shaft 110; when the center rod 130 is placed into the receiving channel and placed at the coupling point of the connecting shaft 110 and the base 210, the connecting shaft 110 and the base 210 can be kept at least radially relative to each other and stationary.
[0099] See also Figure 9The coupling between the connecting shaft 110 and the base 210 can achieve axial relative stillness between the connecting shaft 110 and the base 210, but other parts are needed to achieve radial relative stillness between the connecting shaft 110 and the base 210. For example, one of the first contact surface 112 and the second contact surface 212 has a protrusion 116 and the other has a groove 216. The protruding direction of the protrusion 116 and the recessing direction of the groove 216 are both radial directions of the connecting shaft 110. When at least a portion of the first contact surface 112 contacts the second contact surface 212, the protrusion 116 is embedded in the groove 216. In this way, when the protrusion 116 is fitted into the groove 216, if the connecting shaft 110 needs to move relative to the base 210 along the axial direction of the connecting shaft 110, the protrusion 116 must first be moved away from the groove 216. Since the protruding direction of the protrusion 116 and the recessing direction of the groove 216 are both radial directions of the connecting shaft 110, when the protrusion 116 is moved away from the groove 216, the connecting shaft 110 needs to move radially relative to the base 210. Thus, when the connecting shaft 110 moves axially away from the base 210, the connecting shaft 110 must first move radially relative to the base 210, thereby facilitating the coupling between the connecting shaft 110 and the base 210.
[0100] Furthermore, the first contact surface 112 may include a distal third distal blocking surface 117, a proximal first connecting surface 118, and a proximal third proximal blocking surface 119; the second contact surface 212 may include a distal fourth distal blocking surface 217 for contacting the third distal blocking surface 117, a proximal second connecting surface 218 for contacting the first connecting surface 118, and a proximal fourth proximal blocking surface 219 for contacting the third proximal blocking surface 119. In this case, one of the protrusions 116 and the grooves 216 may be disposed on the first connecting surface 118, and the other may be disposed on the second connecting surface 218. Furthermore, the first connecting surface 118 and the second connecting surface 218 may be parallel to the axis of the connecting shaft 110.
[0101] At this time, the conveying device 100 may also be provided with a central rod 130. The central rod 130 may be configured such that when the central rod 130 is located at the coupling point between the connecting shaft 110 and the base 210, the connecting shaft 110 and the base 210 remain at least radially relative to each other, so as to achieve coupling between the connecting shaft 110 and the base 210. For example, the connecting shaft 110 and the base 210 may be provided with a receiving channel arranged along the axial direction of the connecting shaft 110; when the central rod 130 is placed into the receiving channel and located at the coupling point between the connecting shaft 110 and the base 210, the connecting shaft 110 and the base 210 can remain at least radially relative to each other, thereby achieving a fixed connection between the connecting shaft 110 and the base 210.
[0102] It should be noted that the specific embodiments for the detachable coupling of the connecting shaft 110 and the base 210 in this application are not limited to the specific embodiments described above. In addition to the methods provided in the above embodiments, any other suitable method may be used, such as the method shown in Figures 82A and 82B of the specification in Chinese Patent Document CN102395331B, or the method shown in Figure 84 of the specification in Chinese Patent Document CN102395331B, etc.
[0103] This embodiment does not impose any particular limitation on the number of movable components in the prosthesis. The prosthesis may include only one movable component, namely the first movable component described above. By controlling the movement of the first movable component through the first body 121, changes in the state of the prosthesis can be achieved.
[0104] The prosthesis may also include two movable components, namely the first movable component and the second movable component described above. The first movable component is controlled by the first body 121, and the second movable component is controlled by the second body 141 to change the state of the prosthesis. Of course, the prosthesis may also include more than two movable components, and the movement of one or more of the movable components can be controlled by the body in the control wire to change the state of the prosthesis.
[0105] The aforementioned “state” can be a change in the structure or shape of the entire prosthesis or a part thereof, such as changing from a compressed state to an unfolded state, or achieving an unlocked state, a locked state, and / or a change from a locked state to an unlocked state between the prosthesis and the target tissue, between the prosthesis and the delivery system, and between the internal components of the prosthesis; “state” can also be a change in the position and / or orientation of the entire prosthesis or a part thereof (e.g., the first movable component).
[0106] Taking a prosthesis that includes a movable component as an example, the prosthesis may be a endovascular stent graft used to treat aortic stenosis. Generally, during delivery, a restraint wire (i.e., the first movable component) is used to restrain the endovascular stent graft in a compressed state. Once the endovascular stent graft is positioned at the target location, the restraint wire is released by a control wire to allow the endovascular stent graft to change from a compressed state to an deployed state.
[0107] Taking a prosthesis comprising two moving parts as an example, the prosthesis could be a valve clip. The valve clip uses the movement of the clamping arm and clamping seat to clamp the edge of the valve leaflet to treat valvular regurgitation. During the process of the valve clip clamping the edge of the valve leaflet, the movement of the clamping arm is controlled by control wires to change the posture of the clamping arm.
[0108] See also Figure 15This explanation will further elaborate on the use of a mitral valve clip 200, a prosthesis used to treat mitral regurgitation, as an example. It should be emphasized that the mitral valve clip 200 is merely an illustrative example; in other embodiments, the prosthesis may not be a mitral valve clip 200, but rather a tricuspid valve clip or other prosthesis used to treat other conditions. This application does not limit the specific type of prosthesis, and this exemplary description does not constitute a limitation of this application.
[0109] Specifically, the mitral valve clip 200 includes a base 210, a clamping arm (i.e., a movable part), and a clamping seat, which are rotatable relative to the axis of the base 210. The clamping arm is located at the proximal end of the base 210, and the clamping seat is located at the distal end of the base 210.
[0110] In some embodiments, the clamping arms include a first clamping arm 220 (i.e., a first movable member) and a second clamping arm 230 (i.e., a second movable member), which are arranged symmetrically about the axis of the base 210.
[0111] It should be emphasized that the first movable member being the first clamping arm 220 and the second movable member being the second clamping arm 230 are merely illustrative examples when the prosthesis is a mitral valve clip 200. In other embodiments, the first movable member may not be the first clamping arm 220 and the second movable member may not be the second clamping arm 230. This application does not limit the specific types of the first and second movable members.
[0112] Similarly, the clamping seat includes a first clamping seat 240 and a second clamping seat 250, which are symmetrically arranged about the axis of the base 210 and located on the plane containing the first clamping arm 220 and the second clamping arm 230, so as to better clamp the edges of the anterior and posterior leaflets of the mitral valve 700. Here, "the plane containing the first clamping arm 220 and the second clamping arm 230" refers to the plane formed by the axis of the first clamping arm 220 and the axis of the second clamping arm 230; "the first clamping seat 240 and the second clamping seat 250 are located on the plane containing the first clamping arm 220 and the second clamping arm 230" means that the axes of the first clamping seat 240 and the second clamping seat 250 are both located on the plane containing the first clamping arm 220 and the second clamping arm 230. After the mitral valve clip 200 is delivered to the target position of the mitral valve 700, the anterior and posterior leaflets of the mitral valve 700 are clamped between the clip arm and the clip seat by driving the rotation of the clip arm and the clip seat, thereby achieving the treatment of mitral regurgitation.
[0113] Specifically, see [link to relevant document] Figure 1 , Figure 2 and Figure 15In one example, both the first clamping arm 220 and the second clamping arm 230 are sheet-like, and are elastically connected by a transition portion 221. Further, the transition portion 221 is located at the distal end of the base 210. Preferably, the first clamping arm 220, the transition portion 221, and the second clamping arm 230 are integrally formed, creating a shape resembling an inverted Ω. Furthermore, the first clamping arm 220 and the second clamping arm 230 are in an extended state in their natural state. Figure 2 As shown, when the first body 121 is lifted, the first clamping arm 220 is driven to rotate upward and approach the base 210, and the first clamping arm 220 undergoes elastic deformation. When the first body 121 is pushed, the first clamping arm 220 rotates away from the base 210 and returns to its original state. Correspondingly, when the second body 141 is lifted, the second clamping arm 230 is driven to rotate upward and approach the base 210, and the second clamping arm 230 undergoes elastic deformation. When the second body 141 is pushed, the second clamping arm 230 rotates away from the base 210 and returns to its original state.
[0114] See also Figure 1 and Figure 2 Both the first clamping seat 240 and the second clamping seat 250 are rotatably connected to the base 210. Preferably, the first clamping seat 240 and the second clamping seat 250 are rotatably connected to the base 210 via the same pivot. Preferably, the cross-sectional shape of the first clamping seat 240 perpendicular to the axial direction is U-shaped to better wrap the first leaflet edge 710 and the first clamping arm 220 of the mitral valve 700. Similarly, the cross-sectional shape of the second clamping seat 250 perpendicular to the axial direction is U-shaped to better wrap the second leaflet edge 720 and the second clamping arm 230 of the mitral valve 700. When the mitral valve clamp 200 clamps the leaflet of the mitral valve 700, the first clamping seat 240 and the second clamping seat 250 are driven to rotate and compress the leaflet edge of the mitral valve 700 as well as the first clamping arm 220 and the second clamping arm 230, thereby achieving the clamping of the mitral valve clamp 200 on the leaflet of the mitral valve 700.
[0115] In this embodiment, there are no particular limitations on how the first body 121 controls the movement of the first movable component and the second body 141 controls the movement of the second movable component. For the mitral valve clamp 200, it is sufficient that the first body 121 is movably connected to the first clamping arm 220. Thus, on the one hand, the first clamping arm 220 can rotate with the movement of the first body 121; on the other hand, when the delivery device 100 needs to separate from the mitral valve clamp 200, the first control wire 120 can separate from the first clamping arm 220. The relationship between the second body 141 and the second clamping arm 230 is similar and will not be described further.
[0116] In some implementations, see also Figure 1 , Figure 3 , combined Figures 16 to 18 The first body 121 extends distally from the first preset channel 300, and after reaching the position of the first clamping arm 220, extends proximally to the conveying device 100. Thus, the first body 121 forms a curved portion at the position of the first clamping arm 220, and the curved portion interpenetrates with the first clamping arm 220 or an accessory disposed on the first clamping arm 220 to facilitate control of the rotation of the first clamping arm 220.
[0117] In this embodiment, the first locking body 122 is configured to be detachable from the first clamping arm 220. Thus, when it is necessary to remove the first control wire 120 from the first clamping arm 220, it can be ensured that the first locking body 122 can be removed from the first clamping arm 220.
[0118] See Figure 16 In some embodiments, the aforementioned accessory is a fixing line 222, which is set on the first clamping arm 220 by means of bundling, knotting, etc., and the fixing line 222 forms a fixing line body 223 for interpenetrating with the curved portion of the first body 121.
[0119] Specifically, the fixing wire body 223 is annular to form a first through hole for interpenetrating with the aforementioned curved portion. The fixing wire 222 also has a fixing knot 224 connected to the fixing wire body 223, and the fixing knot 224 is disposed on the first clamping arm 220. The curved portion of the first body 121 passes through the first through hole to interpenetrate with the fixing wire body 223.
[0120] Furthermore, the first clamping arm 220 has a second through hole 225 on its surface. The fixing wire body 223 passes through the second through hole 225 from the side of the first clamping arm 220 away from the base 210. The fixing knot 224 is disposed on the side of the first clamping arm 220 away from the base 210, and the fixing knot 224 is configured to not pass through the second through hole 225.
[0121] Alternatively, the fixing knot 224 of the fixing wire 222 is wrapped around the second through hole 225 to securely connect with the first clamping arm 220.
[0122] See Figure 17 In some embodiments, the first clamping arm 220 is provided with two third through holes 226. The end of the first body 121 away from the first clamping body 122 (i.e., the end of the bent portion) passes through one third through hole 226 from the side of the first clamping arm 220 away from the first clamping seat 240, and then passes through the other third through hole 226 from the side of the first clamping arm 220 near the first clamping seat 240. In this way, the bent portion of the first body 121 can interpenetrate with the first clamping arm 220.
[0123] Alternatively, the first clamping arm 220 is provided with more than two even-numbered third through holes 226, and the end of the first body 121 away from the first locking body 122 (i.e., the end of the bent portion) alternately passes through these third through holes 226. In this way, the bent portion of the first body 121 can also interpenetrate with the first clamping arm 220.
[0124] See Figure 18 In some embodiments, the first clamping arm 220 is provided with a protrusion 227, and the protrusion 227 on the first clamping arm 220 is provided with a fourth through hole 228. The end of the first body 121 away from the first clamping body 122 (i.e., the end of the bent portion) passes through the fourth through hole 228. In this way, the bent portion of the first body 121 can also interpenetrate with the first clamping arm 220. Preferably, the extending direction of the fourth through hole 228 is the same as the extending direction of the first clamping arm 220.
[0125] It should be noted that the connection method between the second body 141 and the second clamping arm 230 can be referred to the connection method between the first body 121 and the first clamping arm 220 described above, and will not be repeated here.
[0126] Alternatively, the second clamping body 142 can also be configured to be detachable from the second clamping arm 230. In this way, when it is necessary to remove the second control wire 140 from the second clamping arm 230, it can be ensured that the second clamping body 142 can be removed from the second clamping arm 230.
[0127] Furthermore, the mitral valve clip 200 also includes an actuation assembly for controlling the rotation of the first clamping seat 240 and the second clamping seat 250.
[0128] Continue to refer to Figure 1 , Figure 2 The actuation assembly includes a first connecting rod 261, a second connecting rod 262, and a slider 263. The proximal end of the first connecting rod 261 is rotatably connected to a first clamping seat 240, and the distal end is rotatably connected to the slider 263, which can move axially relative to the base 210. Thus, the first connecting rod 261, the first clamping seat 240, the base 210, and the slider 263 form a motion mechanism similar to a crank-slider mechanism. When the slider 263 is driven closer to or away from the base 210, the first clamping seat 240 is driven to rotate. Similarly, the proximal end of the second connecting rod 262 is rotatably connected to a second clamping seat 250, and the distal end is rotatably connected to the slider 263. Likewise, the second connecting rod 262, the second clamping seat 250, the base 210, and the slider 263 also form a motion mechanism similar to the aforementioned crank-slider mechanism. When the slider 263 is driven closer to or away from the base 210, the second clamping seat 250 is driven to rotate.
[0129] Furthermore, the slider 263 is T-shaped, meaning it includes a horizontal portion and a vertical portion. The two ends of the horizontal portion of the slider 263 are rotatably connected to the first connecting rod 261 and the second connecting rod 262, respectively. The vertical portion of the slider 263 is detachably connected to the central rod 130, for example, via a threaded connection. Thus, the slider 263 can be driven to move relative to the central rod 130, causing the first clamping seat 240 and the second clamping seat 250 to rotate. Preferably, the first connecting rod 261 and the second connecting rod 262 are symmetrically arranged about the axis of the base 210. Thus, when the slider 263 moves the first clamping seat 240 and the second clamping seat 250, the rotation angle of the first clamping seat 240 is the same as the rotation angle of the second clamping seat 250.
[0130] Preferably, the conveying device 100 further includes: a conduit 150 sleeved on the connecting shaft 110, the conduit 150 having two channels extending along the axial direction of the conduit 150; the end of the first body 121 away from the first clamping body 122 passing through the channel from the far end of one channel and extending to the proximal end of the channel, and the end of the second body 141 away from the second clamping body 142 passing through the channel from the far end of the other channel and extending to the proximal end of the channel.
[0131] This allows the operator to easily lift the end of the first body 121 away from the first clamping body 122 at the proximal end of the catheter 150 to adjust the rotation angle of the first clamping arm 220, and also allows the operator to easily lift the end of the second body 141 away from the second clamping body 142 at the proximal end of the catheter 150 to adjust the rotation angle of the second clamping arm 230.
[0132] When it is necessary to separate the first control wire 120 and the second control wire 140 from the mitral valve clamp 200, both the first preset channel 300 and the second preset channel 600 are adjusted to the second state. The operator pulls the end of the first body 121 away from the first clamp 122 and the end of the second body 141 away from the second clamp 142 at the proximal end of the catheter 150 to separate the first control wire 120 and the second control wire 140 from the mitral valve clamp 200.
[0133] Those skilled in the art will understand that the above-described embodiments are specific examples of implementing this application, and in practical applications, various changes in form and detail may be made without departing from the spirit and scope of this application. Any person skilled in the art can make their own modifications and alterations without departing from the spirit and scope of this application; therefore, the scope of protection of this application should be determined by the scope defined in the claims.
Claims
1. A prosthetic system, characterized by, The system comprises: a delivery device and a prosthesis; the delivery device comprises a connecting shaft and a first control wire; the prosthesis comprises a base and a first movable member, wherein the base is detachably coupled with the connecting shaft; a first preset channel is arranged on the connecting shaft or the base at an angle with respect to the axis of the connecting shaft, and the first preset channel comprises oppositely arranged first and second ports; the first control wire comprises a first body and a first clamping body connected thereto, the size of at least the part of the first body connected to the first clamping body is smaller than the size of the first clamping body, the first clamping body is located in the first preset channel, and the first body extends out of the first preset channel from the first port to independently drive the first movable member to move; a blocking member is arranged to block the second port to prevent the first clamping body from escaping from the second port; wherein the first preset channel has a first state and a second state, when the first preset channel is in the first state, the first clamping body is constrained in the first preset channel; when the first preset channel is in the second state, the first clamping body is allowed to be separated from the first preset channel at the first port; the part of the connecting shaft or the base provided with the first preset channel is a preset segment; the blocking member is a hollow structure, the blocking member is sleeved and fixed on the preset segment, and part of the inner wall surface of the blocking member is arranged to cover the second port to block the port; the outer wall surface of the preset segment has a first clamping portion, and the inner wall surface of the blocking member has a second clamping portion, wherein when the blocking member is sleeved on the preset segment, the second clamping portion and the first clamping portion are clamped with each other; the first clamping portion is a recess formed by the inward recess of the outer wall surface of the preset segment, and the second clamping portion is a contraction portion formed by the inward contraction of the inner wall surface of the blocking member, wherein the recess surrounds the axis of the preset segment for one turn, the contraction portion surrounds the axis of the preset segment for one turn, and the contraction portion is clamped in the recess to make the second clamping portion and the first clamping portion clamped with each other; or the first clamping portion is a protrusion formed by the outward protrusion of the outer wall surface of the preset segment, and the second clamping portion is an expansion portion formed by the outward expansion of the inner wall surface of the blocking member, wherein the protrusion surrounds the axis of the preset segment for one turn, the expansion portion surrounds the axis of the preset segment for one turn, and the protrusion is clamped in the expansion portion to make the second clamping portion and the first clamping portion clamped with each other.
2. The prosthesis system according to claim 1, wherein when the first preset channel is in the first state, the minimum size of the first preset channel is a first size, the first size is at least greater than the size of the part of the first body connected to the first clamping body and smaller than the size of the first clamping body; when the first preset channel is in the second state, the minimum size of the first preset channel is a second size, the second size is greater than the size of the first clamping body.
3. The prosthesis system according to claim 1 or 2, wherein The delivery device further comprises a central rod; The connecting shaft is provided with a receiving channel arranged axially along the connecting shaft, or the connecting shaft and the base are provided with a receiving channel arranged axially along the connecting shaft; The central rod is movably received in the receiving channel; The receiving channel intersects the first preset channel, and a region where the receiving channel intersects the first preset channel is a coincident region; When the central rod occupies at least part of the coincident region, the first preset channel is in the first state; When the central rod is outside the coincident region, the first preset channel is in the second state.
4. The prosthesis system according to claim 3, wherein When the first preset channel is in the first state, the first clamping body is located in a defined space defined by the occlusion member, the central rod and the first preset channel; An outer surface of the central rod and a wall surface on a side of the first preset channel opposite the coincident region form a limiting section; The first body extends from the defined space and extends out of the first preset channel from the first port after passing through the limiting section.
5. The prosthesis system according to claim 4, wherein When the first preset channel is in the first state, the limiting section has a third size, the third size being greater than a size of a portion of the first body connected to the first clamping body and smaller than a size of the first clamping body.
6. The prosthesis system according to claim 1, wherein The occlusion member is further provided with a first opening, the first opening is arranged opposite the first port to expose the port, and the first opening has a size greater than or equal to a size of the first clamping body.
7. The prosthesis system according to claim 1, wherein The occlusion member comprises a covering portion and a blocking portion, the blocking portion is used to be placed in the second port to block the second port, and the covering portion is used to be arranged outside the second port.
8. The prosthesis system according to claim 1, wherein The delivery device further comprises a second control wire; The prosthesis further comprises a second movable member; A second preset channel is arranged in the connecting shaft or the base at an angle with respect to the axis of the connecting shaft, the second preset channel comprises oppositely arranged third and fourth ports; The second control wire comprises a second body and a second clamping body connected thereto, at least a portion of the second body connected to the second clamping body has a size smaller than a size of the second clamping body, the second clamping body is located in the second preset channel, and the second body extends out of the second preset channel from the third port to independently drive the second movable member to move; The occlusion member is further used to occlude the fourth port to prevent the second clamping body from escaping from the fourth port. The second preset channel has a first state and a second state, when the second preset channel is in the first state, the second card body is constrained in the second preset channel; when the second preset channel is in the second state, the second card body is allowed to separate from the second preset channel at the third port.
9. The prosthesis system according to claim 8, wherein, when the first preset channel and the second preset channel are arranged on the connecting shaft or the base, the axis of the first preset channel and the axis of the second preset channel are arranged in axial misalignment on the connecting shaft, or the axis of the first preset channel and the axis of the second preset channel intersect and are arranged at an angle.
10. The prosthesis system according to claim 8, wherein, the prosthesis is a mitral valve clip or a tricuspid valve clip.
11. The prosthesis system according to claim 8, wherein, the first movable member is a first clamping arm, and the second movable member is a second clamping arm, the first clamping arm and the second clamping arm rotate about the axis of the base; the first body is movably connected to the first clamping arm, and the second body is movably connected to the second clamping arm.
Citation Information
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